The Identification and Quantitation of Low-Level Compounds for Impurity and Degradation Analyses

In this webinar you learn how to have a structured approach to minor component identifications that are the acceptable.

John C. Fetzer
John C. Fetzer
Friday, May 14, 2021
10:00 AM PDT | 01:00 PM EDT
90 Minutes

More Trainings by this Expert   Product Id : 503783

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$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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In the development and approval process for new medicines and pharmaceuticals, 2 important tests focus on compounds of low concentrations - impurity and degradation product analyses.

Analytically this means identifying these compounds and assessing their amounts. A variety of chromatographic and spectroscopic techniques can be used, often in combination. This webinar covers some example approaches and the validation issues that must be met and maintained.

Why you should Attend: Identifying and quantitating minor components is mandatory.

The use of an acceptable approach with its backing by validation and documentation ensures that these analyses will be acceptable.Reliance on corroborating data and the documentation to show this is the key.

  • To learn how to have a structured approach to minor component identifications that are the acceptable
  • Understanding the validation and documentation needs for the different approaches
  • The use of libraries versus manual data interpretation
  • Using the interconnection between data
  • Completing the cycle - checking that an identification is correct
  • On-going strategies

Areas Covered in the Session:
  • Qualitative approaches to identification
  • Selectivity of identification
  • The use of complementary data
  • Peak shape, peak purity, and retention time as validation
  • The importance of a standard reference or surrogate
  • On-going diligence

Who Will Benefit:
  • Lab Chemists
  • Lab Managers
  • Lab Technicians
  • Lab Analysts
  • Industries into Compliance Methodology (Biotech, Pharma)
  • Companies into Environmental Compliance or EPA

Speaker Profile
John C. Fetzer has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers onl iquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.

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